Sanofi Plans Regulatory Filing for Diabetes Combo Drug
Sanofi provided a projected timeline for regulatory filings for LixiLan, a fixed-ratio combination of insulin glargine and lixisenatide, for treating Type II diabetes following initial results from a Phase III clinical trail that tested patients with Type 2 diabetes treated with metformin. Insulin glargine is the active ingredient in Sanofi’s top-selling product, Lantus and follow-on product, Toujeo, both for treating diabetes, and lixisenatide is the active ingredient in Lyxumia, for treating Type II diabetes. Lixisenatide was discovered by Zealand Pharma A/S of Denmark and licensed and developed by Sanofi.
The combination therapy is important for Sanofi as it faces generic competition for Lantus, its top-selling product in 2014 with sales of EUR 6.344 billion ($$6.92 billion) and patent expiry, effective in February 2015 in the US and in May 2015 in the European Union. Toujeo is a next-generation, once-daily basal insulin based on insulin glargine, which is the active ingredient Lantus. Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist for treating Type II diabetes. It was approved in Europe in 2013 for treating adults with Type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, when they do not provide adequate glycemic control. Lixisenatide is currently approved in over 50 countries worldwide, with commercial launches in most European Union (EU) countries, Japan, Brazil, Mexico and other markets. Lixisenatide is an investigational product in the US. It will be resubmitted to the US Food & Drug Administration (FDA) in the third quarter of 2015.
The recent study investigated the efficacy and safety of a once-daily single injection of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide versus treatment with insulin glargine 100 units/mL over a 30-week period patients whose Type 2 diabetes was not adequately controlled at screening on a basal insulin with or without oral anti-diabetic drugs. The study will be completed in third quarter 2015. Following an analysis of results, Sanofi will determine the next steps in the regulatory process. Currently, regulatory submissions are planned for the fourth quarter of 2015 in the United States and the first quarter 2016 in the EU.